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Borghaei H, Langer CJ, Gadgeel S, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Chih-Hsin Yang J, Gubens M, Sequist LV, Awad MM, Fiore J, Saraf S, Keller SM, Gandhi L
24-Month Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab As First-Line Therapy for Advanced Nonsquamous Non-Small-Cell Lung Cancer
J Thorac Oncol (2019) 14:124-129.
Abstract
INTRODUCTION: Cohort G of KEYNOTE-021 (NCT02039674) evaluated the efficacy and safety of pembrolizumab plus pemetrexed-carboplatin (PC) versus PC alone as first-line therapy for advanced nonsquamous NSCLC. At the primary analysis (median follow-up, 10.6 months), pembrolizumab significantly improved objective response rate (ORR) and progression-free survival (PFS); hazard ratio (HR) for overall survival (OS) was 0.90 (95% CI, 0.421.91). Herein, we present an updated analysis. METHODS: 123 patients with previously untreated stage IIIB/IV nonsquamous NSCLC without EGFR/ALK aberrations were randomized 1:1 to 4 cycles of PC with/without pembrolizumab 200 mg Q3W. Pembrolizumab treatment continued for 2 years; maintenance pemetrexed was permitted in both groups. Eligible patients in the PC alone group with radiologic progression could cross over to pembrolizumab monotherapy. P values are nominal (one-sided P<0.025). RESULTS: As of December 1, 2017, median follow-up was 23.9 mo. ORR was 56.7% with pembrolizumab plus PC versus 30.2% with PC alone (estimated difference, 26.4%; 95% CI, 8.9%42.4%; P=0.0016). PFS was significantly improved with pembrolizumab plus PC versus PC alone (HR, 0.53; 95% CI, 0.330.86; P=0.0049). 41 patients in the PC alone group received subsequent anti-PD-1/anti-PD-L1 therapy. The HR for OS was 0.56 (95% CI, 0.320.95; P=0.0151). 41% of patients in the pembrolizumab plus PC group and 27% in the PC alone group had grade 35 treatment-related adverse events. CONCLUSIONS: Significant improvements in PFS and ORR with pembrolizumab plus PC versus PC alone observed in the primary analysis were maintained and the HR for OS with 24-month median follow-up was 0.56, favoring pembrolizumab plus PC.
Note
Publication Date: 2019-01-01.
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Last updated on Friday, December 06, 2019